(40 days)
The Duo™ Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and six months of non-operative treatment. The Duo device is designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
The Duo™ Lumbar Interbody Fusion Device is an intervertebral implant designed to provide mechanical support of the intradiscal space as an adjunct to fusion. The device is made of PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum. The Duo implant is available in varying lengths and heights with two lordotic configurations, and is provided sterile. The device is designed with a porous central cavity for graft containment, rounded nose to aid implant insertion, and ridged teeth to resist migration.
I am sorry, but the provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Duo™ Lumbar Interbody Fusion Device." It describes the device, its intended use, indications for use, and a comparison to a predicate device. It also mentions some non-clinical testing for surgical instrumentation modifications.
However, the document does NOT contain any information about acceptance criteria for the device's performance, nor does it describe any study that proves the device meets such criteria.
Therefore, I cannot provide the requested information about:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results that would typically be found in a clinical trial report or a more extensive technical file.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.